Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial
Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial
复制标题
DOI：
10.1016/s0140-6736(10)60673-3
复制
发表时间：
2010-07-17
期刊：
影响因子：
168.9
通讯作者：
Goldstein, Jay L.
中科院分区：
文献类型：
--
作者：
Chan, Francis K. L.;Lanas, Angel;Goldstein, Jay L.
背景环氧化酶（考克斯）-2-选择性非甾体抗炎药（NSAID）和非选择性NSAID加质子泵抑制剂（PPI）具有相似的上消化道结局，但选择性药物的整个胃肠道临床结局风险可能低于非选择性药物。我们的目的是比较与塞来昔布与双氯芬酸缓释加omeprazol.Methods胃肠道事件的风险，我们进行了为期6个月的，双盲，随机试验，骨关节炎或类风湿性关节炎患者在胃肠道风险增加，在32个国家或地区的196个中心。患者幽门螺杆菌检测阴性，年龄≥ 60岁或≥ 18岁，既往有胃十二指肠溃疡。我们使用计算机生成的随机化方案，以1：1的比例将患者分配至塞来昔布200 mg每日两次或双氯芬酸缓释剂75 mg每日两次+奥美拉唑20 mg每日一次。患者和研究者均对治疗分配设盲。主要终点是由独立委员会裁定的具有临床意义的上消化道或下消化道事件的复合终点。该试验在ClinicalTrials.gov注册，编号NCT 00141102。结果4484例患者被随机分配到治疗组（2238例塞来昔布; 2246例双氯芬酸+奥美拉唑），并被纳入意向治疗分析。20例（0.9%）接受塞来昔布治疗的患者和81例（3.8%）接受双氯芬酸+奥美拉唑治疗的患者符合主要终点标准（风险比4.3，95% CI 2.6-7.0; p
Background Cyclo-oxygenase (COX)-2-selective non-steroidal anti-inflammatory drugs (NSAIDs) and non-selective NSAIDs plus a proton-pump inhibitor (PPI) have similar upper gastrointestinal outcomes, but risk of clinical outcomes across the entire gastrointestinal tract might be lower with selective drugs than with non-selective drugs. We aimed to compare risk of gastrointestinal events associated with celecoxib versus diclofenac slow release plus omeprazole.Methods We undertook a 6-month, double-blind, randomised trial in patients with osteoarthritis or rheumatoid arthritis at increased gastrointestinal risk at 196 centres in 32 countries or territories. Patients tested negative for Helicobacter pylori and were aged 60 years and older or 18 years and older with previous gastroduodenal ulceration. We used a computer-generated randomisation schedule to assign patients in a 1:1 ratio to receive celecoxib 200 mg twice a day or diclofenac slow release 75 mg twice a day plus omeprazole 20 mg once a day. Patients and investigators were masked to treatment allocation. The primary endpoint was a composite of clinically significant upper or lower gastrointestinal events adjudicated by an independent committee. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00141102.Findings 4484 patients were randomly allocated to treatment (2238 celecoxib; 2246 diclofenac plus omeprazole) and were included in intention-to-treat analyses. 20 (0.9%) patients receiving celecoxib and 81 (3.8%) receiving diclofenac plus omeprazole met criteria for the primary endpoint (hazard ratio 4.3, 95% CI 2.6-7.0; p